Molly R. Grammel

At Goodwin, Molly has been an active member of teams litigating ten trials, including five federal jury trials. She has also worked on appellate matters in the Federal Circuit, the First Circuit, and the Supreme Judicial Court of Massachusetts, as well as inter partes review proceedings.

Representative matters include:

• In re Aflibercept Patent Litigation, No. 24-md-3103 (N.D.W. Va.) and Regeneron Pharmaceuticals, Inc. v. Sandoz Inc., C.A. No. 24-08760 (D.N.J.); representing Sandoz in BPCIA litigation concerning proposed biosimilar to Eylea® (aflibercept) filed in New Jersey and in a related multi-district litigation, involving more than 40 asserted patents concerning pharmaceutical formulations, dosing regimen, biologic manufacturing methods, devices, etc.
• Certain Disposable Vaporizer Devices, Inv. No. 337-TA-1410 and Certain Disposable Vaporizer Devices and Components and Packaging Thereof, Inv. No. 337-TA-1381 (USITC); representing manufacturers of regulated products in defending unfair competition and patent infringement claims in two related investigations at the International Trade Commission, leading to withdrawal of one complaint on the eve of trial in the first investigation and a denial of request for a temporary exclusion order in the second investigation.
• In re: HIV Antitrust Litigation, C.A. No. 19-02573-EMC (N.D. Cal.) and related suits in New Mexico and Pennsylvania trial courts; defended Teva Pharmaceuticals against reverse-payment antitrust claims challenging prior settlement of Hatch Waxman patent litigation brought by Gilead regarding Teva’s generic versions of Viread® (tenofovir), Truvada® (tenofovir/emtricitabine), and Atripla® (tenofovir/emtricitabine/efavirenz). Member of stand-up trial team securing a total defense verdict of no anticompetitive reverse payment and no market power, following six-week N.D. Cal. jury trial seeking damages of $3.8 billion (before mandatory trebling) from defendants Teva and Gilead Sciences. Member of team challenging at the New Mexico Supreme Court the exercise of personal jurisdiction over Teva in New Mexico.
• Novartis Vaccines and Diagnostics, Inc. et al. v. Genentech, Inc., C.A. No. 21-04874-EJD (N.D. Cal.) and C.A. No. 21-02892 (CA Super. Ct.) (on remand); representing Novartis in antibody engineering patent license dispute relating to Novartis’s Cosentyx® (secukinumab) and Ilaris® (canakinumab) products, seeking $209.5 million in damages and defending cross-claim for payment of post-expiration royalties.
• Teva Pharmaceuticals International GmbH et al. v. Eli Lilly and Company, C.A. Nos. 18-12029-ADB, 21-10954-ADB (D. Mass.); representing Teva in two suits asserting Teva patents regarding anti-CGRP antibodies against Eli Lilly’s Emgality® (galcanezumab) product, which is approved for overlapping indications with Teva’s Ajovy® (fremanezumab). Member of stand-up trial team obtaining $176.5 million damages verdict and finding of no invalidity following a four-week jury trial.
• Certain Pre-Filled Syringes for Intravitreal Injection and Components Thereof, Inv. No. 337-TA-1207 (USITC); Novartis Pharma AG et al v. Regeneron Pharmaceuticals, Inc., C.A. No. 20-00690-DNH (N.D.N.Y); Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, et al., IPR2020-01317, IPR2020-01318, IPR2021-00816 (P.T.A.B.). Represented Novartis in ITC investigation and related litigations and inter partes review proceedings relating to assertion of Novartis pre-filled syringe patent against Regeneron’s EYLEA® (aflibercept) product.
• Genentech, Inc. et al. v. Celltrion, Inc. et al., C.A. Nos. 18-95-CFC, 18-1025-CFC (D. Del.). Represented Celltrion and Teva in BPCIA dispute regarding proposed biosimilar to HERCEPTIN® (trastuzumab) involving 40 asserted patents, including during the pre-suit patent dance and during ensuing litigation. Obtained settlement on the eve of expedited trial that permitted launch of HERZUMA® (trastuzumab) in March 2020.
• Reckitt Benckiser Pharmaceuticals Inc. et al. v. Dr. Reddy’s Laboratories, S.A. et al., No. 14-1451-RGA (D. Del.); Reckitt Benckiser Pharmaceuticals Inc. et al. v. Dr. Reddy’s Laboratories, S.A. et al., C.A. Nos. 17-7111-KM, 18-1775-KM, 18-5288-KM (D.N.J.). Represented Dr. Reddy’s in Hatch-Waxman suit and second-wave litigation regarding Dr. Reddy’s proposed generic versions of SUBOXONE® (buprenorphine/naloxone) sublingual films. Member of stand-up trial team in first suit, securing a defense judgment of non-infringement of all asserted claims, affirmed on appeal following two-week bench trial. Participated in preliminary injunction proceedings in second suit and successful expedited appeal therefrom securing ability to launch.The case concluded with a favorable settlement under which Dr. Reddy’s received $72 million.
• Veracode, Inc. et al v. Appthority, Inc., No. 12-10487-DPW (D. Mass.). Represented patent owner in three-week jury trial  bringing infringement claims against a competitor, resulting in verdict and post-trial judgment as a matter of law of willful infringement and entry of a permanent injunction. The affirmed damages award exceeded the infringer’s profits
• Various non-public representations, including advising global innovator pharmaceutical company contemplating patent assertion suits against competitors, counseling biosimilar developer in pre-litigation matters, and confidential arbitration proceedings involving pharmaceutical IP licensing disputes between innovators.

In addition to her IP work, Molly was also one of the Goodwin attorneys on the team that defended former SAC Capital Advisors portfolio manager Mathew Martoma in a four-week S.D.N.Y. jury trial. In the largest-ever insider trading prosecution brought to trial, Mathew faced charges that he improperly obtained non-public information about the results of a high-profile pharmaceutical clinical trial and used this information to make trades resulting in profit and avoided losses of over $275 million. Molly was also a member of a Goodwin trial team defending employment and contract claims in a three-week E.D. Mo. jury trial.

Pro Bono

Molly devotes a significant portion of her practice to pro bono matters. In 2020 and 2022, Molly led teams winning two contested immigration trials, obtaining grants of asylum for Ugandan refugees who fled to the United States following persecution in their home country on the basis of their sexual orientation. Molly has also assisted legal permanent residents in applying for U.S. citizenship and is currently representing four young girls in their green card applications after obtaining awards of Special Immigrant Juvenile status based on abuse or neglect in their home country.

In addition to these matters, in 2017, Molly completed a six-month rotation with the Middlesex County District Attorney’s Office. During this time, she first-chaired fifteen trials, including five jury trials. Molly also argued dozens of evidentiary and non-evidentiary motions, including successfully arguing for the admissibility of presumptively excluded evidence at a consolidated hearing addressing a group of cases brought in Woburn District Court prior to 2014.

Molly has contributed to the following publications and presentations:

• Editor, Big Molecule Watch, Goodwin’s award-winning blog that reports real-time analysis and updates on regulatory issues, litigation, legislation and other news in the developing world of biosimilars.
• Co-author, “Chapter 8: Mediating Section 337 Disputes Regarding Infringing Imports at the International Trade Commission,” ADR Advocacy, Strategies, and Practices for Intellectual Property and Technology Cases, Forthcoming Third Edition.
• Co-author, “Protecting Data in the MedTech Industry,” MedTech Intelligence, August 2019

Molly has contributed to the following presentations:

• Speaker, “The Fate of the Therapeutic Dosing Regimen: Trends and Considerations in Validity Challenges to Dosing Patent Claims,” Goodwin Webinar, March 2024
• Speaker, “AI in Education:  Privacy and Data Security Considerations,” Goodwin Higher Education Symposium Webinar, October 2021
• Speaker, “Biosimilars Patent Challenges at the PTAB,” Goodwin Webinar, May 2020
• Speaker, “Traditional and Alternative Dispute Resolution Methods,” New England Corporate Counsel Association Seminar, March 2020
• Speaker, “Unlocking the Value of Data in MedTech: Protect Your IP, Protect Your Business: Trade Secrets Deep Dive (Part 2),” Goodwin Webinar, April 2019
• Speaker, “Unlocking the Value of Data in MedTech: Protections, Pitfalls, and Strategies (Part 1),” Goodwin Webinar, March 2019
• Speaker, “Practical Strategies for Pharmaceutical Companies in U.S. Patent Litigation,” Goodwin, Taiwan Research-based Biopharmaceutical Manufacturers Association, and Taiwan Generic Pharmaceutical Association Seminar, January 2016
• Speaker, “Recent Supreme Court Decisions in Patent Cases – How Helpful Have They Been?” Practicing Law Institute - Patent Litigation 2015 Seminar, November 2015
• Speaker, “Teva v. Sandoz SCOTUS Decision,” Goodwin Webinar, February 2015
• Speaker, “Patent Litigation 2014: Recent Development and Changes in Patent Law and Their Effects on Patent Litigation,” Practicing Law Institute - Patent Litigation 2014 Seminar, November 2014